Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/25/2018 |
| Start Date: | January 2008 |
| End Date: | December 2011 |
Contingency Management Plus Levodopa/Carbidopa for Treatment of Cocaine Dependence
Cocaine dependence is a major public health problem and the development of a treatment for
this disorder is a priority. To date, treatment interventions based on positive incentive
principles have shown the strongest effects for improving substance use outcomes. One such
example is contingency management (CM) interventions in which nondrug rewards are used to
compete with cocaine. Recent evidence suggests that certain medications improve response to
CM interventions, particularly agents that target dopamine reward systems in the brain. A
promising dopamine-enhancing medication is levodopa. The study team has observed the
strongest effects of levodopa when the medication is administered in the context of CM
therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is
designed to further evaluate this promising treatment approach. Cocaine dependent outpatients
will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical
trial. CM will be behavioral therapy platform for both treatment groups. The study will test
the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing
cocaine use. This study is expected to validate the usefulness of a new
behavioral-pharmacological treatment approach for cocaine dependence.
this disorder is a priority. To date, treatment interventions based on positive incentive
principles have shown the strongest effects for improving substance use outcomes. One such
example is contingency management (CM) interventions in which nondrug rewards are used to
compete with cocaine. Recent evidence suggests that certain medications improve response to
CM interventions, particularly agents that target dopamine reward systems in the brain. A
promising dopamine-enhancing medication is levodopa. The study team has observed the
strongest effects of levodopa when the medication is administered in the context of CM
therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is
designed to further evaluate this promising treatment approach. Cocaine dependent outpatients
will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical
trial. CM will be behavioral therapy platform for both treatment groups. The study will test
the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing
cocaine use. This study is expected to validate the usefulness of a new
behavioral-pharmacological treatment approach for cocaine dependence.
Inclusion Criteria:
- between 18 and 60 years of age
- meet Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV)
criteria for current cocaine dependence.
- be in acceptable health on the basis of interview, medical history and physical exam.
Exclusion Criteria:
- current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine,
marijuana, or nicotine.
- have a DSM-IV axis I psychiatric disorder or neurological disease or disorder
requiring ongoing treatment and/or making study participation unsafe.
- have significant current suicidal or homicidal ideation.
- have medical conditions contraindicating levodopa/carbidopa pharmacotherapy.
Conditions include severe pulmonary disease (bronchial asthma, emphysema),
cardiovascular disease (severe or history of myocardial infarction with residual
arrhythmias), narrow angle glaucoma, melanoma, history of peptic ulcer, renal function
impairment.
- taking medications known to have significant drug interactions with levodopa/carbidopa
(e.g., monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol,
phenothiazines, selegiline, anesthetics).
- currently or recently (last 3 months) treated for substance use or another psychiatric
condition.
- having conditions of probation or parole requiring reports of drug use to officers of
the court.
- impending incarceration.
- pregnant or nursing for female patients.
- inability to read, write, or speak English.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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